15 sep
|
Eli Lilly
|
Alcobendas
15 sep
Eli Lilly
Alcobendas
Experteer Overview
As a Sr Principal (R4+) - Global Quality Systems Lead at Lilly, you will oversee and advance the global quality system processes across value streams. You will ensure alignment with the QMS strategy and governance to support Commercial and Clinical Supply functions. You’ll partner with cross-functional teams to drive compliance, risk management, and quality improvements across the operational controls pillar. This is a high-impact role shaping quality standards and capability across the organization, with a meaningful focus on patient safety and regulatory readiness.
Compensaciones / Beneficios
• Oversee interpretation and approval of general quality system processes with process owners and networks
• Lead governance, management reviews, process monitoring, and prioritization for the Operational Controls pillar
• Develop and implement quality system improvements, including standards, training, tools, and performance metrics
• Collaborate with manufacturing, suppliers, marketing quality operations, Ru0026D, Clinical Supply, and other functions to manage process risks and standardize processes
• Monitor regulatory developments,
support inspection readiness, and engage with external bodies to influence quality policies
Responsabilidades
• 7+ years of direct cGMP experience with strong knowledge of cGMP requirements and quality systems
• Experience in at least one modality such as QC labs, cell and gene therapy, or parenteral manufacturing
• Fluent in English; additional languages preferred
• Experience with Quality Risk Management and global quality system governance
• Knowledge of US/EU GMPs, ICH, PIC/S, and WHO expectations
• Formal training in Lean, CI, or Quality Risk Management
• Ability to work independently and collaboratively, communicate effectively, and present to varied audiences
• Continuing education or higher science degree and/or facility/start-up experience considered a plus
Requisitos principales
• company bonus (depending on performance)
• 401(k) participation
• pension
• medical/dental/vision benefits
• flexible benefits (healthcare spend accounts)
• life insurance and related benefits
📌 Sr Principal Global Quality Systems Lead (Alcobendas)
🏢 Eli Lilly
📍 Alcobendas